Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice.

To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice.

It had two arms (groups): A (active comparator) and B (active comparator).

This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.

This is the control group, following the physician's standard practice.

The registry classes the interventions as drug.

Who Took Part

The registry lists 9 actual participants took part.

It was open to people of any sex aged from 21 years up to 74 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with type 2 diabetes. BMI \< 40 kg/m2 and \>25 kg/m2. Ability and willingness to follow a tight anti-diabetic therapy and to perform SMBG controls.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: pregnant women or women with the intention of becoming pregnant; women with childbearing potential who will not use contraceptive protection; breastfeeding women.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2008-01 with completion listed for 2009-03.

It ran at 1 site in Argentina.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Minor, severe and nocturnal Hypoglycaemic events (safety).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.